(116 days)
The Port Access System is indicated for use in laparoscopic procedures to the abdominal and thoracic cavities while maintaining pneumoperitoneum.
The Port Access System consists of reusable and single use components sold in various configurations. The ports accommodate laparoscopic instrument diameters from 5mm up to the diameter indicated on the chosen accompanying cannula. All single use parts are sterlised using gamma irradiation and supplied to the customer in a sterile condition.
In order to obtain access to the surgical site during laparoscopic surgery, the trocar is introduced into the cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the single use seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments.
This document is a 510(k) Premarket Notification from the FDA regarding a device called the "Port Access System." It details the device's indications for use, comparison with a predicate device, and performance data. However, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI-powered system or a study involving human readers.
Here's why the prompt's requested information cannot be fully extracted from the provided text:
- Type of Device: The "Port Access System" is a surgical instrument (laparoscopic port system), not an AI-powered diagnostic or decision-making tool. Therefore, many of the requested criteria (e.g., AI model performance metrics, ground truth establishment for AI, MRMC studies) are not applicable.
- Nature of Performance Data: The performance data discussed are related to the physical characteristics and functionality of the surgical device (biocompatibility, sealing performance, insertion force, fatigue, shelf life, cleaning/sterilization), not to diagnostic accuracy or human interpretation tasks.
- Absence of Specific Acceptance Criteria Table: While safety and effectiveness are general criteria, there isn't a table of specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, AUC) and reported device performance against those criteria in the context of an AI study.
- No Clinical Studies: The document explicitly states, "No Clinical Studies were conducted as part of this submission. Non-Clinical Testing was sufficient to demonstrate substantial equivalence to the predicate device." This means there would be no data on human reader performance, expert ground truth, or adjudication methods in a clinical setting for this device regarding diagnostic or interpretive tasks.
Given the context of the provided document, the following points can be addressed, and others explicitly stated as not applicable or not found:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable for the type of device described (surgical instrument, not AI/diagnostic). The document broadly states "safety and effectiveness" and "performs within its design specifications" were evaluated through non-clinical testing. Specific numerical acceptance criteria for functional performance tests (e.g., maximum insertion force, minimum seal integrity) are likely present in the underlying test reports but are not provided in this summary document.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for individual non-clinical tests. The tests were performed on components and the system itself (e.g., seals, cannulas, trocars). This is not a "dataset" in the sense of AI or clinical studies.
- Data Provenance: The device is manufactured by Surgical Innovations Limited in the United Kingdom. Testing was conducted to US FDA guidance and international standards (ISO 10993-1).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. "Ground truth" in the context of AI or diagnostic accuracy studies is not relevant for a physical surgical instrument's mechanical and material performance testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements in expert interpretations, which is not relevant for the non-clinical testing of a surgical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC comparative effectiveness study was not done. The device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This concept is not applicable as the device is a physical surgical port system, not an algorithm.
7. The type of ground truth used
Not applicable in the sense of diagnostic/AI ground truth. For the non-clinical tests, the "ground truth" would be the measured physical properties and performance characteristics against pre-defined engineering specifications and regulatory standards. For example, "sealing performance" would be measured directly against a specified leakage rate.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.